Our research group, the Basel Pharmacoepidemiology Unit, conducts observational research using large databases, primarily the UK-based General Practice Research Database. We have a close research collaboration with the Boston Collaborative Drug Surveillance Program www.bcdsp.net at Boston University in the United States. Our main focus of interest is drug safety, but we also conduct studies in the area of disease epidemiology or drug utilization. We have an intense collaboration with the pharmaceutical industry who approaches us for study projects and for consulting. We apply standard methodology used in epidemiological research such as cohort or case-control analyses. In addition to conducting research using large automated databases, we start looking into additional options such as analyzing data from computerized records at the Basel University Hospital, and we intend to work with Swiss electronic health data on a national level in the near future.

This database www.gprd.com from the UK is one of the largest and best-validated databases for observational research in the world. It was established around 1987 and encompasses currently some five million people who are enrolled with selected general practitioners (GPs), covering more than 50 million patient-years of follow-up. The patients enrolled in the GPRD are representative of the UK with regard to age, sex, geographic distribution and annual turnover rate. GPs have been trained to record medical information including demographic data, medical diagnoses, hospitalizations, deaths and drug prescriptions using standard software and standard coding systems. The GPs generate prescriptions directly with the computer; this information is automatically transcribed into the computer record. It contains the name of the preparation, route of administration, dose, and number of tablets for each prescription. The recorded information on drug exposure and diagnoses has been validated and proven to be of high quality. The GPRD has been the source of over several hundred studies published in peer-reviewed journals. All our study protocols require approval by ISAC, the Independent Scientific Advisory Committee for MHRA database research. We share a license with the BCDSP which allows us to use this database for research purposes.

A major focus of our research is drug safety. Randomized trials often provide limited information regarding the long-term safety of drugs. Large automated databases with large groups of drug users allow conducting long-term studies and detecting and quantifying rare adverse effects of drugs. This research is called the "post-marketing study phase" or "Phase IV". We follow-up on interesting and timely safety issues and are currently conducting studies on an broad range of drugs, such as for example postmenopausal hormones, antidiabetic drugs, lipid-lowering agents, antipsychotic drugs, or antihypertensives.

Drug companies are increasingly taking on proactive approaches to study the safety of future drugs in development, before they get on the market. If a drug has been associated with certain safety issues in the early phases of development, or if the mechanism of action of a drug makes it likely that certain adverse effects may be seen and reported later on after marketing, it makes sense to study the disease which is supposed to be treated with this future drug (i.e. the indication) in detail and to quantify the frequency of such outcomes before the drug becomes available on the market. For example, if an immuno-modulating drug is being developed for rheumatoid arthritis and is expected to be linked to lymphoma in spontaneous reports once the drug is used by a large number of patients, it is important to quantify background rates of lymphomas in patients with rheumatoid arthritis before this drug is on the market. These background rates allow putting future spontaneous reports into perspective of how many new cases of lymphoma would have been expected in this group of patients, independent of the newly launched drug. We are currently conducting large projects in the area of psoriasis, Parkinson's disease, Alzheimer's disease and COPD.